Turbine blood pumps.

After years of development and preclinical testing, clinical trials of the MicroMed DeBakey VAD began in November 1998 in Europe and in June 2000 in the United States. As of August 2000, 44 patients in Europe and 3 patients in the United States have undergone implantation with the MicroMed DeBakey VAD. In conclusion, data from the European clinical trial of the MicroMed DeBakey VAD support the safety and performance of the device. Results show that the device provides adequate left ventricular and circulatory support in patients with end-stage heart failure without unduly jeopardizing patient safety. Moreover, the device provides advantages not inherent to commercially available pulsatile devices: (1) miniature size, enabling implantation in smaller patients; (2) ease of implantation; (3) reduced surgical bleeding; and (4) a low incidence of postoperative infections, often a limiting factor with other devices. The MicroMed DeBakey VAD European clinical trial is the first demonstration of the compatibility of continuous blood flow with adequate tissue perfusion and overall maintenance of life for up to 4.5 months. This initial experience with the MicroMed DeBakey VAD suggests that the pump can provide circulatory support to bridge patients to cardiac transplantation and may provide an improved quality of life for the patient with end-stage heart failure.